Bisoprolol (versus unexposed) - Medication and Pregnancy KB

Bisoprolol (versus unexposed)

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Delteil 2024	France 2004 - 2021 retrospective cohort (claims database)	EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques) database, and the Registre des Handicaps de l'Enfant en Haute-Garonne (RHE31), Haute-Garonne, France.	Pregnancies with at least one dispensed prescription of Bisoprolol during pregnancy (between last menstrual period and delivery).	unexposed (general population or NOS) Pregnancies without dispensed prescription of beta-blockers and other anti-hypertensive agents during pregnancy.	at least 1st trimester	93 / 172284	When available, data in women with chronic pathology (hypertension or cardiac), treated at least during the 1st trimester were preferred to all indications (including gestational hypertension, ...). Exposure at least T1 considered as chronic indications.
Delteil 2024	France 2004 - 2021 retrospective cohort (claims database)		Women's drug exposure during pregnancy was estimated on the basis of dispensed prescription drugs recorded by the French Assurance Maladie.		at least 1st trimester	93 / 172284
Fitton (Controls unexposed, disease free) 2020	Scotland 2010 - 2014 retrospective cohort (claims database)	Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division.	All women who had a singleton birth and who were dispensed at least one prescription for Bisoprolol during the 300 days before birth (whatever the indication).	unexposed, disease free All women who had a singleton birth during the same study period who were not dispensed antihypertensive medication during or 60 days following pregnancy, and who did not have an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension).	during pregnancy (anytime or not specified)	106 / 250693	The majority of offspring were exposed to a β-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of >1 antihypertensive medication (20.53%, 1403 children).
Fitton (Controls unexposed, disease free) 2020	Scotland 2010 - 2014 retrospective cohort (claims database)		The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents.		during pregnancy (anytime or not specified)	106 / 250693
Fitton (Controls unexposed, sick) 2020	Scotland 2010 - 2014 retrospective cohort (claims database)	Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division.	All women who had a singleton birth and who were dispensed at least one prescription for Bisoprolol during the 300 days before birth (whatever the indication).	unexposed, sick All women who had a singleton birth during the same study period, who had an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension) and who were not dispensed antihypertensive medication at any stage during or 60 days after pregnancy.	during pregnancy (anytime or not specified)	106 / 7971	The majority of offspring were exposed to a β-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of >1 antihypertensive medication (20.53%, 1403 children).
Fitton (Controls unexposed, sick) 2020	Scotland 2010 - 2014 retrospective cohort (claims database)		The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents.		during pregnancy (anytime or not specified)	106 / 7971
Hoeltzenbein 2018	Germany 2000 - 2015 prospective cohort	The German Embryotox pharmacovigilance institute.	Pregnancies with bisoprolol exposure at least during the first trimester. Concomitant therapy with other antihypertensive drugs except angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) was possible.	unexposed, disease free Nonhypertensive pregnancies, without use of beta-blockers and other antihypertensives during pregnancy, randomly selected.	at least 1st trimester	339 / 678	The most frequent treatment indications for bisoprolol were hypertension (203/339, 60%) and arrhythmias (115/ 339, 34%). The daily dose was within the recommended range [median 5 mg; min–max 1.25–20mg; information available in 295/339 pregnancies].
Hoeltzenbein 2018	Germany 2000 - 2015 prospective cohort	The German Embryotox pharmacovigilance institute.	At the initial contact (during pregnancy) maternal characteristics and detailed exposure assessment are asked for after informed consent. The outcome of pregnancy was not known at the time of enrollment.		at least 1st trimester	339 / 678
Ishibashi 2017	Japan 2000 - 2016 retrospective cohort	15 Japanese institutions.	Pregnancies in long QT patients with Bisoprolol therapy.	unexposed, sick Pregnancies in long QT patients without β-blocker therapy.	during pregnancy (anytime or not specified)	10 / 94	Exposure: 10 bisoprolol (5mg/day, 0.072±0.028mg/kg/day).
Ishibashi 2017	Japan 2000 - 2016 retrospective cohort	15 Japanese institutions.	All data were collected with checking their maternity record book.		during pregnancy (anytime or not specified)	10 / 94	Exposure: 10 bisoprolol (5mg/day, 0.072±0.028mg/kg/day).
Tanaka 2016	Japan 2000 - 2010 retrospective cohort	The National Cerebral and Cardiovascular Center in Osaka, Japan.	Pregnant women with cardiovascular disease treated with Atenolol for at least 2 weeks before delivery.	unexposed, sick Pregnant women with cardiovascular disease who were not treated with an oral α/β- or β-adrenergic blocker randomly identified over the same period.	during pregnancy (anytime or not specified)	5 / 100	Maternal cardiovascular diseases: congenital heart disease and pulmonary hypertension; aortic disease; valvular heart disease; coronary artery disease and acute coronary syndrome; cardiomyopathy and heart failure; and arrhythmia.
Tanaka 2016	Japan 2000 - 2010 retrospective cohort		Patient data were collected from their medical records and included medication(s) used (β-blockers and other ones).		during pregnancy (anytime or not specified)	5 / 100
Vaclavik 2024	The Czech Republic 2012 - 2022 population based cohort retrospective	The National Registry of Reproductive Health (NRRZ) and the National Registry of Reimbursable Health Services (NRHZS).	Births whose mothers were prescribed Bisoprolol during pregnancy (for pre-existing hypertension or pregnancy-induced hypertension).	unexposed, disease free Births whose mothers had no hypertension.	during pregnancy (anytime or not specified)	-9 / -9
Vaclavik 2024			The National Registry of Reimbursable Health Services (NRHZS).		during pregnancy (anytime or not specified)	-9 / -9

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

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